Levofloxacin Lactate Tablets

This product has a broad-spectrum antibacterial effect and strong antibacterial effect. It has strong antibacterial activity against most Enterobacteriaceae, such as Escherichia coli, Klebsiella, Proteus, Salmonella, Shigella, and Gram-negative bacteria such as Haemophilus influenzae, Legionella pneumophila, and Neisseria gonorrhoeae. It also has antibacterial effects on Gram-positive bacteria such as Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, and Mycoplasma pneumoniae and Chlamydia pneumoniae, but has poor effects on anaerobic bacteria and enterococci. This product is the levorotatory form of ofloxacin, and its in vitro antibacterial activity is about twice that of ofloxacin. Its mechanism of action is to inhibit the activity of bacterial DNA gyrase, prevent the synthesis and replication of bacterial DNA, and cause bacterial death.

Levofloxacin lactate.

This product is a film-coated tablet, which appears off-white or slightly yellowish green after removing the film coating.

Applicable to infections caused by sensitive bacteria: 1. Urinary and reproductive system infections, including simple and complicated urinary tract infections, bacterial prostatitis, urethritis or cervicitis caused by Neisseria gonorrhoeae. 2. Respiratory tract infections, including acute bronchial infections and lung infections caused by sensitive Gram-negative bacilli. 3. Gastrointestinal infections caused by Shigella, Salmonella, enterotoxigenic Escherichia coli, Aeromonas hydrophila, Vibrio parahaemolyticus, etc. 4. Typhoid fever. 5. Bone and joint infections. 6. Skin and soft tissue infections. 7. Systemic infections such as sepsis.

Oral. Common dosage for adults: 1. Bronchial infection and lung infection: 0.2g once, twice a day, or 0.1g once, 3 times a day, for a course of 7 to 14 days. 2. Acute simple lower urinary tract infection: 0.1g once, twice a day, for a course of 5 to 7 days; complicated urinary tract infection: 0.2g once, twice a day, or 0.1g once, 3 times a day, for a course of 10 to 14 days. 3. Bacterial prostatitis: 0.2g once, twice a day, for a course of 6 weeks. Common dosage for adults is 0.3 to 0.4g per day, divided into 2 to 3 times. If the infection is severe or the sensitivity of the pathogen is poor, such as Pseudomonas aeruginosa and other Pseudomonas bacterial infections, the therapeutic dose can be increased to 0.6g per day, divided into 3 times.

1. Gastrointestinal reactions: abdominal discomfort or pain, diarrhea, nausea or vomiting. 2. Central nervous system reactions may include dizziness, headache, drowsiness or insomnia. 3. Allergic reactions: rash, skin itching, occasionally exudative erythema multiforme and angioneurotic edema. Photosensitivity reactions are less common. 4. Occasionally, the following may occur: ① epileptic seizures, mental abnormalities, irritability, confusion, hallucinations, and tremors. ② interstitial nephritis manifestations such as hematuria, fever, and rash. ③ phlebitis. ④ crystalluria, which is more common when used in high doses. ⑤ joint pain. 5. A small number of patients may experience elevated serum aminotransferases, increased blood urea nitrogen, and decreased peripheral white blood cells, which are mostly mild and transient.

Patients who are allergic to this product and fluoroquinolones are contraindicated.

Precautions for children: The safety of this product in infants and adolescents under 18 years of age has not been determined. However, this product can cause joint lesions when used in several young animals. Therefore, it should not be used in children and adolescents under 18 years of age. Precautions for pregnancy and lactation: Animal experiments have not confirmed that quinolones are teratogenic, but studies on the use of drugs in pregnant women have not yet reached a clear conclusion. Since this drug can cause joint lesions in underage animals, it is contraindicated for pregnant women, and lactating women should suspend breastfeeding when using this product. Precautions for the elderly: Elderly patients often have impaired renal function, and since this product is partially excreted through the kidneys, it needs to be used in reduced doses.

1. Urine alkalinizing agents can reduce the solubility of this product in urine, leading to crystalluria and nephrotoxicity. 2. When quinolone antibiotics are used in combination with theophylline, competitive inhibition of the cytochrome P450 binding site may lead to a significant reduction in the liver elimination of theophylline, a prolonged blood elimination half-life (t1/2β), an increase in blood drug concentration, and the appearance of symptoms of theophylline poisoning, such as nausea, vomiting, tremor, restlessness, excitement, convulsions, palpitations, etc. This product has little effect on the metabolism of theophylline, but the blood concentration of theophylline should still be measured and the dosage adjusted when used in combination. 3. When this product is used in combination with cyclosporine, the blood concentration of cyclosporine can be increased. The blood concentration of cyclosporine must be monitored and the dosage adjusted. 4. When this product is used in combination with the anticoagulant warfarin, although the anticoagulant effect of the latter is slightly enhanced, the patient's prothrombin time should also be closely monitored when used in combination. 5. Probenecid can reduce the secretion of this product from the renal tubules by about 50%. When used together, it may cause toxicity due to the increased blood concentration of this product. 6. This product can interfere with the metabolism of caffeine, thereby reducing the elimination of caffeine, prolonging the blood elimination half-life (t1/2β), and may cause central nervous system toxicity. 7. Antacids and iron preparations containing aluminum and magnesium can reduce the oral absorption of this product and should not be used together. 8. When this product is used in combination with the non-steroidal anti-inflammatory drug fenbufen, convulsions occasionally occur, so it is not suitable for use with fenbufen. 9. This product may cause blood sugar disorders when used in combination with oral hypoglycemic drugs. Therefore, blood sugar concentrations should be monitored during medication. Once hypoglycemia occurs, this product should be discontinued immediately and appropriate treatment should be given.

Keep away from light and store in sealed container.

0.1g (calculated as levofloxacin)

24 months.

Suzhou Yushi Pharmaceutical Co., Ltd.

• Founded in:

  2003-04-02

• Address:

  No. 188, Nanhu Avenue, Nanhu Industrial Zone, Xinzhuang, Changshu City

• Tax NO.:

  913205817473463096

• Registered Funds:

  38 million yuan

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